Ioversol

Ioversol is a radiopaque iodinated contrast agent used as a diagnostic aid in Radiographic Body Imaging, Cerebral Arteriography, Aortography, Computed Tomography (CT scan), Head Imaging, Coronary Arteriography, IV-DSA, and IV Urography. 

• Ioversol is available under the following different brand names: Optiray.

Common side effects of Ioversol include:

• Fever, and
• Nausea

Serious side effects of Ioversol include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Fever,
• Sore throat,
• Burning in the eyes,
• Skin pain,
• Red or purple skin rash that spreads and causes blistering and peeling,
• Skin rash,
• Swollen glands,
• Flu-like symptoms,
• Muscle aches,
• Severe weakness,
• Unusual bruising,
• Yellowing in the skin or eyes (jaundice),
• Lightheadedness,
• Slow heartbeats,
• Unexplained muscle pain,
• Tenderness,
• Weakness,
• Pain, bleeding, or skin changes where the injection was given,
• Sudden numbness or weakness (especially on one side of the body),
• Problems with vision or speech,
• Chest pain or pressure,
• Pain spreading to the jaw or shoulder,
• Little or no urination,
• Swelling in the feet or ankles,
• Tiredness, and
• Shortness of breath

Rare side effects of Ioversol include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable solution

• 160 mg/mL (34%)
• 240 mg/mL (51%)
• 300 mg/mL (64%)
• 320 mg/mL (68%)
• 350 mg/mL (74%)

Radiographic Body Imaging

Adult dosage

• Usual: 50-150 mL intravenous OR 100-250 mL intravenous of (240 mg/mL)
• 25-75 mL intravenous OR 50-150 mL intravenous infusion; not to exceed 150 mL.
• For 240 mg/mL: 35-100 mL intravenous OR 70-200 mL intravenous infusion; not to exceed 250 mL.

Cerebral Arteriography

Adult dosage

• 2-12 mL of 51%, 64%, 68%; may repeat as necessary; not to exceed 200 mL/procedure.
• 20-50 mL aortic arch injection of 51%, 64%, and 68% for a simultaneous 4-vessel study; not to exceed 200 mL/procedure.

Aortography

Adult dosage

• 45 mL (10-80 mL range) of 68%; may repeat as necessary; not to exceed 250 mL/procedure.

Computed Tomography

Adult dosage

• 25-75 mL intravenous bolus followed by 50-150 mL infusion of 74%; not to exceed 150 mL.
• 25-75 mL intravenous bolus followed by 50-150 mL infusion of 68%; not to exceed 150 mL.
• 25-75 mL intravenous bolus followed by 50-150 mL infusion of 64%; not to exceed 150 mL.
• 35-100 mL intravenous bolus followed by 70-200 mL infusion of 51%; not to exceed 150 mL.

Pediatric dosage

• Children below 1 month
  • Safety & efficacy not established.
• Children above 1 month
  • Body imaging: 2 mL/kg (1-3 mL/kg) of 68%
  • Head imaging: 1-3 mL/kg of 68%

Head Imaging

Adult dosage

• 50-150 mL intravenous of 68% or 64% OR
• 100-250 mL intravenous of 51%
• Perform scanning immediately following intravenous administration.

Coronary Arteriography

Adult dosage

• 8 mL (2-10 mL) left coronary; 6 mL (1-10 mL) right coronary; may repeat as necessary; not to exceed 250 mL/procedure.

IV-DSA

Adult dosage

• 160 mg/mL (34%) is recommended.
• 30-50 mL intravenous, repeat as necessary; not to exceed 250 mL/procedure.

IV Urography

Adult dosage

• 50-75 mL intravenous of 74%, 68%, or 64% OR
• 75-100 mL intravenous of 51%
• Higher dosages may be indicated.
• 1.4 mL/kg intravenous of 350 mg/mL; not to exceed 140 mL, OR
• 1.5-2 mL/kg intravenous of 320 mg/mL; not to exceed 150 mL, OR
• 1.5 mL/kg intravenous of 300 mg/mL; not to exceed 150 mL, OR
• 2 mL/kg intravenous of 240 mg/mL; not to exceed 200 mL.

Pediatric dosage

• Children below 1 month
  • Safety & efficacy not established.
• Children above 1 month
  • 0.5-3 mL/kg intravenous (1-1.5 mL/kg usual); not to exceed 3 mL/kg.

Angiocardiography

Pediatric dosage

• Children below 1 month
  • Safety & efficacy not established.
• Children above 1 month
  • 1.25 mL/kg (1-1.5 mL/kg) of 68% or 74% as a single ventricular injection; not to exceed 5 mL/kg or 250 mL total volume.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ioversol has severe interactions with the following drugs.
  • amphotericin B deoxycholate
  • cidofovir
  • neomycin oral
• Iioversol has serious interactions with the following drugs:
  • amikacin
  • metformin
  • streptozocin
  • tacrolimus
  • teicoplanin
• Ioversol has moderate interactions with at least 26 other drugs.
• Ioversol has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Not for intrathecal use (may cause death, convulsions, cerebral hemorrhage, coma, paralysis, ARF)
• Symptomatic hyperthyroidism

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using ioversol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using ioversol?”

Cautions

• Inhibits blood coagulation.
• Caution in severe renal impairment, combined renal/hepatic disease, severe thyrotoxicosis, myelomatosis, anuria, pheochromocytoma, sickle cell, CHF, chronic alcoholism, severe arterial/venous disease.
• May cause renal failure in patients with advanced vascular disease, and diabetes; should be well hydrated before/after the procedure; do not use laxatives, diuretics, or preparatory dehydration before administering a product.
• Obtain a history of allergy, hypersensitivity, or prior hypersensitivity reactions to iodinated contrast agents; always have emergency resuscitation equipment and trained personnel available and monitor all patients for hypersensitivity reactions.
• Allergies (bronchial asthma, hay fever, food allergies) reported.
• Premedication with antihistamines or corticosteroids to avoid or minimize possible allergic reactions should be considered; reports indicate that such pretreatment does not prevent serious life-threatening reactions but may reduce both their incidence and severity.
• General anesthesia may be indicated in the performance of some procedures in selected patients; however, a higher incidence of adverse reactions has been reported in these patients.
• In angiographic procedures, the possibility of dislodging plaques or damaging or perforating the vessel wall should be considered during catheter manipulations and contrast medium injection; test injections are suggested to ensure proper catheter placement.
• Angiography should be avoided whenever possible in patients with homocystinuria because of the risk of inducing thrombosis and embolism.
• Patients with congestive heart failure should be observed for several hours following the procedure to detect delayed hemodynamic disturbances which may be associated with a transitory increase in circulating osmotic load.
• Extreme caution during injection of contrast medium is necessary to avoid extravasation, especially in patients with severe arterial or venous disease.
• Selective coronary arteriography should be performed only in selected patients and those in whom expected benefits outweigh procedural risk; inherent risks of angiocardiography in patients with chronic pulmonary emphysema must be weighed against the necessity for performing this procedure.
• Fatal, thromboembolic events causing myocardial infarction and stroke can occur during angiographic procedures; to minimize thromboembolic events use the meticulous angiographic technique; avoid blood remaining in contact with syringes containing the product, which increases the risk of clotting; avoid angiocardiography in patients with homocystinuria because of risk of inducing thrombosis and embolism.
• Contraindicated in patients with symptomatic hyperthyroidism; thyroid storm reported following intravascular use of iodinated radiopaque agents in patients with hyperthyroidism or with autonomously functioning thyroid nodule; evaluate risk in patients before using the product.
• Hypertensive crisis has occurred after the use of iodinated radiopaque contrast agents in a patient with pheochromocytoma; closely monitor patients when administering product if pheochromocytoma or catecholamine-secreting paraganglioma is suspected; inject a minimum amount of product necessary and have measures for the treatment of hypertensive crisis readily available.
• Iodinated contrast agents may promote sickling in individuals who are homozygous for sickle cell disease; hydrate patients before and following product administration; use the product only if necessary, imaging information cannot be obtained with alternative imaging modalities, and inject the minimum amount necessary.
• Severe cutaneous adverse reactions(SCAR), including Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS), may develop from 1 hour to several weeks after intravascular contrast agent administration; reaction severity may increase and time to onset may decrease with repeat administration of contrast agent; prophylactic medications may not prevent or mitigate severe cutaneous adverse reactions; avoid administering the product to patients with a history of severe cutaneous adverse reaction to the product
• Thyroid dysfunction in pediatric patients
• Thyroid dysfunction characterized by hypothyroidism or transient thyroid suppression reported after both single exposure and multiple exposures to iodinated contrast media in pediatric patients 0 to 3 years of age.
• Younger age, very low birth weight, prematurity, underlying medical conditions affecting thyroid function, admission to neonatal or pediatric intensive care units, and congenital cardiac conditions are associated with an increased risk of hypothyroidism after ICM exposure.
• Pediatric patients with congenital cardiac conditions may be at the greatest risk given that they often require high doses of contrast during invasive cardiac procedures.
• An underactive thyroid during early life may harm cognitive and neurological development and require thyroid hormone replacement therapy.
• After exposure to iodinated contrast media, individualized thyroid function monitoring in pediatric patients 0-3 years of age based on underlying risk factors, especially in term and preterm neonates.
• Pediatric patients 0-3 years of age warrant closer monitoring because an underactive thyroid during early life may harm motor, hearing, and cognitive development and require transient T4 replacement therapy.

Pregnancy and Lactation

• Postmarketing data with product use in pregnant women are insufficient to determine if there is a risk of drug-associated adverse developmental outcomes; literature reports show that the product crosses the placenta and is visualized in the digestive tract of exposed infants after birth; the product crosses the placenta and reaches fetal tissues in small amounts; in animal reproduction studies, no adverse developmental effects were observed following intravenous administration of ioversol to pregnant rats and rabbits at doses 0.35 and 0.71 times, respectively, the maximum recommended human dose
• Lactation
  • There is no information about the presence of the product in human or animal milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production; however, iodinated contrast agents are excreted unchanged in human milk in very low amounts with poor absorption from the gastrointestinal tract of a breastfed infant; the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for product and any potential adverse effects on the breastfed infant from the product or underlying maternal condition; interruption of breastfeeding after exposure to iodinated contrast agents is not necessary because potential exposure of the breastfed infant to iodine is small; however, a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 8 hours (approximately 5 elimination half-lives) after product administration to minimize drug exposure to the breastfed infant